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June 16, 2014 Colleen Rogers Center for Drug Evaluation and Research

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June 16, 2014 Colleen Rogers Center for Drug Evaluation and Research June 16, 2014 Colleen Rogers Center for Drug Evaluation and Research Food and Drug Administration Building 22, Room 5411 10903 New Hampshire Avenue Silver Spring, MD 20993 Re: Proposed Rule: Proposed Amendment of the Tentative Final Monograph, Federal Register, Vol. 78, No. 242, Tuesday, December 17, 2013. Docket identification (ID) number: FDA-1975-N-0012 Regulatory Information Number: 0910-AF69 Dear Ms. Rogers: The American Cleaning Institute (ACI)1 appreciates this opportunity to provide comments on the proposed rule to amend the 1994 tentative final monograph (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products to establish conditions under which OTC consumer antiseptic products intended for use with water (referred to throughout as consumer antiseptic washes) are generally recognized as safe and effective. ACI has a specific interest in triclosan (TCS) within the proposed rule since our members produce consumer antiseptic wash products containing triclosan and manufacture triclosan. Triclosan-containing consumer antiseptic wash products play a beneficial role in the daily hygiene routines of millions of people throughout the U.S. and worldwide. They have been and are used safely and effectively in homes, hospitals, schools and workplaces every single day. Furthermore, triclosan and products containing it are regulated by a number of governmental bodies around the world and have a long track record of human and environmental safety which is supported by a multitude of science-based, transparent risk analyses. ACI members are concerned that FDA has not appropriately assessed the safety data that are available prior to proposing that additional safety data are necessary to support the safety of triclosan for this use. According to the agency’s proposed rule, triclosan is the most studied 1 ACI is a trade association representing the $30 billion U.S. cleaning products industry. ACI members include the formulators of soaps, detergents, and general cleaning products used in household, commercial, industrial and institutional settings; companies that supply ingredients and finished packaging for these products; and oleochemical producers. Center for Drug Evaluation and Research 2 Food and Drug Administration June 16, 2014 active ingredient for OTC antiseptic use for both safety and efficacy. FDA, however, neglected a substantial amount of relevant information beyond what is reported in the notice. Studies related to the safety and efficacy of ticlosan are cited and described in these comments. The following summarizes our response to the points raised in the proposed rule and the attachment provides detailed comments on these points. 1. The extensive triclosan database on absorption, distribution, metabolism and excretion (ADME) has demonstrated similarities in absorption, distribution, metabolism (ADM) between species as well as differences in excretion. This is especially relevant in that hamster data is sufficiently similar to human data, therefore, justifying extrapolation with minimal allometric scaling. These data remove the necessity of additional testing. Metabolism is similar following oral and dermal exposures. 2. In vivo carcinogenicity studies in three species (hamster, rat, mouse) additionally supported by extensive in vitro and in vivo mutagenicity studies demonstrate that triclosan is not a carcinogen based on assessments by both FDA and EPA. 3. Based on the above information, the ongoing dermal carcinogenicity study is not necessary. Concern about triclosan dermal photolysis to “dioxins” does not take into consideration that the most likely photolysis product, 2,8-dichlorobenzodioxin, is considered toxicologically inert based on the recognized toxicology equivalence factor (TEF) concept. 4. Extensive in vivo studies demonstrate that triclosan exhibits reproductive no observable effect levels (NOELs) that provide a wide margin of safety to humans under existing use conditions. 5. The existing database of in vitro, in vivo animal and human studies does not support a conclusion that triclosan causes hormonal effects in humans at actual relevant exposure concentrations. The reports of high throughput screening and animal studies showing thyroid or other hormonal activity demonstrated both effect and no-effect levels as expected in adequately designed studies. Extrapolation of these findings, based on dose and relevance of effect, provides a wide margin of safety to humans. 6. The clinical evaluation of actual real-life antimicrobial (antiseptic) resistance has conclusively demonstrated no relevant association between triclosan exposure and microbial resistance to antibiotics. 7. The proposed new FDA standard of demonstrating efficacy by use of clinical population studies is inherently flawed. It requires an infection/disease reduction standard that is not necessary. As long as FDA accepts that antimicrobials (antiseptics) have been adequately shown to have the ability to decrease bacterial (or other relevant organisms) populations, it can control usage by limiting claims. The new standard assumes a claim that would be the exception rather than the rule. Only those wishing this exception would have to meet the clinical population standard. This differentiation would allow FDA to meet their standards for efficacy and safety within a reasonable timeline. Triclosan has demonstrated both in vitro and in vivo efficacy utilizing formulations that have Center for Drug Evaluation and Research 3 Food and Drug Administration June 16, 2014 demonstrated infection control in clinical situations and dermal bacterial reduction in consumer settings. Regarding efficacy testing, FDA should reconsider the new efficacy testing requirements presented in its proposed rule, which are unprecedented. Given the significance of the proposed change to the testing requirements for Consumer Antiseptics and the lack of precedent for this action, FDA should withdraw the proposed rule and reissue it as an Advance Notice of Proposed Rulemaking (ANPR) to give industry and other stakeholders an opportunity to engage with FDA on the generally recognized as effective (GRAE) testing requirements for the active ingredients and surrogate endpoint testing of final formulations. FDA’s efficacy requirements are unjustified by the risk-benefit analysis. Typically, reassessments of benefits and risks are prompted by a safety signal, such as the appearance of a particular sign, symptom, or symptom-complex. However, there has been no demonstration of a scientifically confirmed risk associated with the usage of consumer antiseptic products. There is only speculation around potential risks associated with endocrine disruption and antimicrobial resistance, without consideration of the full weight of evidence or a properly conducted risk assessment. This reliance on speculation to justify unparalleled testing requirements is unwarranted and is not justified on a scientific basis. Furthermore, the FDA does not appear to have considered the potential risks for having an increase in infection(s), including food-borne illness(es), among consumers by their not having access to antibacterial product formulations. This is consistent with FDA's failure to make public their assessment of a safety risk in accordance with accepted transparent scientific principles recognized by the FDA. FDA’s proposed clinical trial requirements are unrealistic and infeasible. We believe that the testing of active ingredients for efficacy, rather than a formulation, is unnecessary and counter to the positions taken by FDA during the lifetime of this monograph as well as other monographs. To this end, we ask that FDA clearly differentiate between active ingredient and final formulation requirements as well as consider simulation testing and surrogate endpoints which are more reasonable than testing for reduced infection rate. ACI urges FDA to revise its proposed in vitro testing methods. We recommend that FDA require MIC/MLC testing of active ingredients on the ATCC reference strains described in the proposed rule to determine the spectrum of antibacterial activity. ACI urges the agency to adopt American Society for Testing and Materials (ASTM) Method E2783 (Standard Test Method for Assessment of Antimicrobial Activity for Water Miscible Compounds Using a Time-Kill Procedure) as the standard for conducting the Time-Kill testing for speed of antimicrobial effect for evaluation of formulated antiseptics. We request, however, that FDA reconsider the performance criteria, which are more demanding than the performance abilities of approved healthcare antiseptic products and likely the unformulated active ingredients. Recognizing that the use of standardized test methods is critical for regulatory testing and approval to assure consistency, FDA should adopt, as appropriate, established and accepted methodology to support the surrogate endpoint efficacy testing for finished antiseptic formulations, such as the following ASTM methods: E1174 - Standard Method for the Evaluation of Health Care Handwash Formulation, E2783 - Standard Test Method for Assessment of Antimicrobial Activity for Water Miscible Compounds Using a Time-Kill Center for Drug Evaluation and Research 4 Food and Drug Administration June 16, 2014 Procedure, and E2784 - Standard Test Method for Evaluation of the Effectiveness of Handwash Formulations Using the Paper Towel (Palmar) Method of Hand Contamination. In summary, the available toxicological information provides no evidence for data gaps or gives cause for concern
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